Safety & Efficacy Study of the Adiana System for Women Who Desire Permanent Birth Control (Sterilization)

Inclusion Criteria: * • Women aged 18 to 45 * Women who are seeking permanent contraception * Women who are at risk of becoming pregnant * Willing to risk becoming pregnant when relying on the Adiana device for contraception * Relatively normal uterine cavity, uterine wall thickness, and uterine size as demonstrated by pelvic sonography * Willing to keep a coital/menstrual log * Have at least one confirmed pregnancy and one living child * Monogamous relationship with a partner who has proven fertility * Sexually active (at least 4 acts of intercourse per month) * Willing to use alternate contraception (either a barrier method or oral contraceptive pills or other monthly, cyclic, hormonal birth control) during the three months following device placement prior to relying on the Adiana device for contraception * Willing and able to maintain in regular contact with the investigator * Women with regular, cyclical menses within 2 months prior to the device placement procedure * Able to provide informed consent Exclusion Criteria: * Women who are unsure of their desire to end their fertility * Presence of gross genital infection, including sepsis * Presence of chlamydia, gonorrhea or syphilis * Presence of genital cancer (note: CIN1 is acceptable) * Intra-uterine pathology which would prevent optimal access to the tubal ostium and intramural portion of the fallopian tube, such as large submucous fibroids or uterine adhesions * History of chronic pelvic pa…